{
  "abstract": "Introduction Addition of bevacizumab and paclitaxel as induction therapy prior to standard atezolizumab and nab-paclitaxel in patients with programmed death-ligand 1 (PD-L1)-positive metastatic triple-negative breast cancer (mTNBC) may help to overcome vascular endothelial growth factor-associated resistance mechanisms that limit the immune-mediated antitumour efficacy of atezolizumab and nab-paclitaxel.Methods and analysis The Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+TNBC (INDUCE) study is a multicentre, randomised, open-label, phase II trial designed to evaluate the efficacy and safety of two cycles of induction therapy with bevacizumab and paclitaxel followed by atezolizumab and nab-paclitaxel compared with standard atezolizumab and nab-paclitaxel in patients with PD-L1-positive mTNBC. The primary outcome of the study is progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumours, V.1.1. We have estimated that 89 PFS events are needed to allow a power of 80% to detect a difference between treatment groups at a one-sided significance level of 10% in this study. The target sample size is set to 106 patients to account for dropouts.Ethics and dissemination The study protocol and informed consent form have been approved by the Certified Research Review Board at the Nagoya University Graduate School of Medicine, Nagoya, Japan. Study results will be presented at international conferences and published in a peer-reviewed journal.Trial registration number jRCTs041240039 NCT06793553.",
  "authors": [
    {
      "affiliations": [
        "Department of Breast Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan"
      ],
      "name": "Yukinori Ozaki"
    },
    {
      "affiliations": [
        "Department of Immunogenomic Medicine, Research Institute, National Cancer Center, Tokyo, Japan",
        "Division of Cancer Immunology, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, Chiba, Japan",
        "Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan"
      ],
      "name": "Shohei Koyama"
    },
    {
      "affiliations": [
        "Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Satoshi Morita"
    },
    {
      "affiliations": [
        "Department of General Surgery (Breast and Endocrine Groups), Tohoku University Hospital, Sendai, Japan"
      ],
      "name": "Minoru Miyashita"
    },
    {
      "affiliations": [
        "Department of Medical Oncology, Fukushima Medical University, Fukushima, Japan"
      ],
      "name": "Emi Tokuda"
    },
    {
      "affiliations": [
        "Department of Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Tatsunori Shimoi"
    },
    {
      "affiliations": [
        "Division of Cancer Immunology, Research Institute, National Cancer Center, Tokyo, Japan"
      ],
      "name": "Megumi Fukuoka"
    },
    {
      "affiliations": [
        "Department of Breast Surgical Oncology, Showa University School of Medicine, Tokyo, Japan"
      ],
      "name": "Hiroko Masuda"
    },
    {
      "affiliations": [
        "Department of Breast and Endocrine Surgery, Nagoya University Hospital, Nagoya, Japan"
      ],
      "name": "Yuko Takano"
    },
    {
      "affiliations": [
        "Cancer Treatment Center, Kansai Medical University Hospital, Hirakata, Japan",
        "Department of Clinical Oncology, Kansai Medical University Hospital, Hirakata, Japan"
      ],
      "name": "Nobuhiro Shibata"
    },
    {
      "affiliations": [
        "Department of Breast and Endocrine Surgery, Osaka University Hospital, Suita, Japan"
      ],
      "name": "Tetsuhiro Yoshinami"
    },
    {
      "affiliations": [
        "Department of Hepato-Biliary-Pancreatic and Breast Surgery, Ehime University Hospital, Toon, Japan"
      ],
      "name": "Akari Murakami"
    },
    {
      "affiliations": [
        "Department of Breast Surgery, Naha Nishi Clinic, Naha, Japan"
      ],
      "name": "Kentaro Tamaki"
    },
    {
      "affiliations": [
        "Breast Oncology Service, Saitama Medical University International Medical Center, Hidaka, Japan"
      ],
      "name": "Hiroshi Ishiguro"
    },
    {
      "affiliations": [
        "Department of Medical Oncology, Fukushima Medical University, Fukushima, Japan"
      ],
      "name": "Shigehira Saji"
    },
    {
      "affiliations": [
        "Chugai Pharmaceutical Co., Ltd, Tokyo, Japan"
      ],
      "name": "Asako Miwa"
    },
    {
      "affiliations": [
        "Chugai Pharmaceutical Co., Ltd, Tokyo, Japan"
      ],
      "name": "Junko Matsunaga"
    },
    {
      "affiliations": [
        "Chugai Pharmaceutical Co., Ltd, Tokyo, Japan"
      ],
      "name": "Yue Zheng"
    },
    {
      "affiliations": [
        "Division of Cancer Immunology, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, Chiba, Japan",
        "Division of Cancer Immunology, Research Institute, National Cancer Center, Tokyo, Japan",
        "Department of Immunology, Nagoya University Graduate School of Medicine, Nagoya, Japan",
        "Division of Cancer Immune Multicellular System Regulation, Center for Cancer Immunotherapy and Immunobiology, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Hiroyoshi Nishikawa"
    },
    {
      "affiliations": [
        "Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Norikazu Masuda"
    }
  ],
  "title": "Randomised, multicentre phase II study of bevacizumab and paclitaxel induction followed by atezolizumab and nab-paclitaxel in patients with PD-L1-positive metastatic triple-negative breast cancer: protocol for the INDUCE trial (JBCRG-M10)",
  "uid": "6b440c1d-ad2a-5d39-98fb-8efaa876414d"
}